effect of influenza vaccination after myocardial infarction on cardiac inflammatory response

Conditions: Acute Myocardial Infarction; Cardiovascular Diseases; Inflammatory Response

Summary: the goal of this randomized, double-blind, placebo-controlled clinical trial is to investigate the immunological effects of influenza vaccination outside of the influenza season on arterial inflammation in patients with a recent acute myocardial infarction (ami). the primary objective is to compare the effects of influenza vaccination to those of a placebo in reducing post-myocardial infarction coronary inflammation as measured by coronary computed tomography angiography (ccta). the main questions it aims to answer are: does influenza vaccination reduce arterial inflammation as measured by ccta at week 8 after percutaneous coronary intervention (pci) in comparison to baseline? does influenza vaccination modulate systemic inflammation as measured by blood biomarkers and in-vitro challenge tests at week 8 after pci in comparison to baseline? researchers will compare the effects of influenza vaccination with those of a placebo.

following informed consent patients are randomized in a 1:1 fashion to influenza vaccination or placebo up to 7 days following pci. blood tests for immune cell phenotyping and transcriptomic and proteomic analyses will be collected at baseline and 8 weeks after study inclusion. patients will undergo ctca at baseline (≤ 7 days of an ami) and 8 weeks after pci.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of non-st-segment elevation myocardial infarction * a finalized coronary pci * male or non-fertile female subjects ≥18 years. (females without childbearing potential, postmenopausal women and women with a history of hysterectomy or other medical conditions that preclude pregnancy) * written informed consent * a ccta can be scheduled within 7 days after pci exclusion criteria: * has received influenza vaccination within 6 months * other vaccination planned within 8 weeks (including covid-19 booster doses) * severe allergy to eggs or previous allergic reaction to influenza vaccine * cardiac surgery or staged pci planned within 8 weeks * coronary stent involving the proximal rca * suspicion of febrile illness or acute, ongoing infection * hypersensitivity to the active substances or ingredients of vaxigrip or against any residues, such as eggs (ovalbumin or chicken proteins), neomycin, formaldehyde and octoxinol * subjects with endogenic or iatrogenic immunosuppression that may result in reduced immunization response * inability to provide informed consent * previous randomization in the eliminate trial * any non-cardiovascular condition, e.g. malignancy, with a life expectancy of less than 1 year based on the investigator´s clinical judgement. * contraindication to coronary ct angiography (e.g., inability to lie flat, contraindication to glyceryl trinitrate, previous contrast allergy or contrast-induced nephropathy, severe renal impairment \[egfr \<30 ml/min/1.73 m2\]) * atrial fibrillation * uncontrolled chronic inflammatory disease * unable to comply with protocol requirements

Keywords: coronary computed tomography angiography percutaneous coronary intervention influenza vaccine non st-segment elevation myocardial infarction